NIH Announces New Embryonic Stem Cell Research Regulations
A few hours ago the National Institutes of Health unveiled the Obama administration’s new guidelines for federal funding of embryonic stem cell research. (NIH also released the 49,000 comments they received during the review period.)
Religious groups have differing views on embryonic stem cell research, and to have an honest debate, it’s important to have accurate information. The new regulations ensure (among many other things) that embryos are not sold for profit; only embryos left over from in vitro fertilization — not embryos created for research purposes — are used in federally funded research; and donors receive information about what will be done with embryos and provide written consent. It’s impossible to please all parties on ESC research, but the guidelines reflect a careful approach to a delicate ethical issue.
A section of particular interest — “Eligibility of Human Embryonic Stem Cells for Research with NIH Funding” — explains the criteria donated embryos must meet in order to qualify for federal funding to research. After the jump.
…hESCs should have been derived from human embryos:
1. that were created using in vitro fertilization for reproductive purposes and were no longer needed for this purpose;
2. that were donated by individuals who sought reproductive treatment (hereafter referred to as “donor(s)”) and who gave voluntary written consent for the human embryos to be used for research purposes; and
3. for which all of the following can be assured and documentation provided, such as consent forms, written policies, or other documentation, provided:
1. All options available in the health care facility where treatment was sought pertaining to the embryos no longer needed for reproductive purposes were explained to the individual(s) who sought reproductive treatment.
2. No payments, cash or in kind, were offered for the donated embryos.
3. Policies and/or procedures were in place at the health care facility where the embryos were donated that neither consenting nor refusing to donate embryos for research would affect the quality of care provided to potential donor(s).
4. There was a clear separation between the prospective donor(s)’s decision to create human embryos for reproductive purposes and the prospective donor(s)’s decision to donate human embryos for research purposes…
During the consent process, the donor(s) were informed of the following:
1. that the embryos would be used to derive hESCs for research;
2. what would happen to the embryos in the derivation of hESCs for research;
3. that hESCs derived from the embryos might be kept for many years;
4. that the donation was made without any restriction or direction regarding the individual(s) who may receive medical benefit from the use of the hESCs, such as who may be the recipients of cell transplants.;
5. that the research was not intended to provide direct medical benefit to the donor(s);
6. that the results of research using the hESCs may have commercial potential, and that the donor(s) would not receive financial or any other benefits from any such commercial development;
7. whether information that could identify the donor(s) would be available to researchers.